Recall Z-2138-2016— Synthes (USA) Products LLC

Name: FDA recall Z-2138-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-31

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2016-05-31, terminated 2017-04-25. It names one FDA 510(k) clearance: K994364. Product: Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue. Reason: DePuy Synthes is voluntarily initiating a recall due to affected devices being distributed and or labeled with MR Safety information that does not meet the current ASTM standard..

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2016-05-31
Terminated: 2017-04-25
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K994364 — SYNTHES BUTTON PLATESynthes (Usa)·cleared 2000-03-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue

Reason for recall

DePuy Synthes is voluntarily initiating a recall due to affected devices being distributed and or labeled with MR Safety information that does not meet the current ASTM standard.

Data sourced from openFDA. This site is unofficial and independent of the FDA.